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Clinical Trials/CTRI/2021/04/032937
CTRI/2021/04/032937Not yet recruitingPhase 2

A clinical comparative study on therapeutic formulation of (Ajwain, Tukhme Suddab, Zeera) versus of Tareeq(Diaphoresis) in the management of Simane Mufrit(Obesity)

Central Council for Research in Unani Medicine New Dehli1 site in 1 country42 target enrollmentStarted: April 30, 2021Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
42
Locations
1
Primary Endpoint
Bmi should reduce. Reduction in skin fold thickness

Study Overview

Brief Summary

Obesity is a condition of excess adipose tissue mass.Obesity is divided into three types; Simple obesity or primary obesity, secondary obesity and drug induced obesity. The prevalence of obesity is higher in women than men. The prevalence of obesity is low in people with low socio-economic status and in those who do more physical work. Body Mass Index is best measure for obesity which is equal to weightheight in the meter square (in kg /m²). According to WHO a person is called obese if BMI is >30 and a person is called overweight if BMI is ≥25.4 Some predisposing factors which are responsible for obesity are unhealthy diet, lack of physical activity, and sedentary life style. Apart from these some other causes responsible for obesity are  high energy food, saturated fat, trans- fats, more diet containing high quantity of sugar. In Unani system of medicine obesity is also known as Siman-e-Mufrit. The causes of obesity mentioned in the Unani literature are luxurious life style, lack of exercise,  Muraghghan ghizaen (fatty diet), all Martoob (moist things) which produces Ratubat in the body like Farhat (excess happiness). Many complication of obesity are Gastrointestinal disorders, Pseudo-tumour cereberi, Asthma, Gallstones, Backach.Keeping in view the side effects of modern medicine, nowadays people need the alternative management of obesity. In Unani system of medicine our therapeutic formulation (Ajwain, Tukhm-e-Suddab, Zeera) is effective treatment for the management of obesity as recommended by old Unani physicians. HammÄm is one of the effective regimen for the management of obesity as described in Unani classical texts. Patient is placed into the bath chamber for a duration till the diaphoresis occur ,So in this regard the present study entitled “A clinical comparative study on therapeutic formulation of (Ajwain, Tukhm-e-Suddab, Zeera) versus Tareeq (diaphoresis) in the management of Siman-e-Mufrit (obesity)â€is designed for validation and evaluation of safety and efficacy.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • BMI>30 Waist circumference >102cm in men and 88 cms in women.
  • Patient who are ready to sign the consent.

Exclusion Criteria

  • Patients below 20 and above 60 years.
  • Patients who fail to give the written consent.
  • Pregnant and lacatating women.
  • Patients having local wounds and infections.
  • Unstable, bed ridden and mentally retarded patients Patients of portal hypertension , cardiovascular disease, bleeding disorders, diabetes mellitus and contraceptive treatment.

Outcomes

Primary Outcomes

Bmi should reduce. Reduction in skin fold thickness

Time Frame: 60 days

Secondary Outcomes

  • Lipid profile cbc ecg(60 days)

Investigators

Sponsor
Central Council for Research in Unani Medicine New Dehli
Sponsor Class
Research institution

Study Sites (1)

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